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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K161913
Device Name AOS Small Fragment Plating System
Applicant
Advanced Orthopaedic Solutions, Inc. (Aos)
3203 Kashiwa St.
Torrance,  CA  90505
Applicant Contact ALEX BHASKARLA
Correspondent
Advanced Orthopaedic Solutions, Inc. (Aos)
3203 Kashiwa St.
Torrance,  CA  90505
Correspondent Contact ALEX BHASKARLA
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HTN   HWC  
Date Received07/12/2016
Decision Date 11/04/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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